FLUGEN INC — Department of Health and Human Services SBIR Phase II: NIAID

Description

Seasonal influenzafluvirusan NIAID category C priority pathogencauses widespread infectionresulting in at leastmillion cases of severe illness anddeaths worldwideWhile annual vaccination is recommended for all individuals aged overmonths in the UScurrent vaccines are only aroundeffective and there is an urgent need for safemore effective influenza vaccines that offer broad spectrum protectionTo meet this needFluGen has developed a novellive replication deficient influenza virusM SRthat can be modified to encode the viral antigens from any influenza A or B strainWe have shown that the influenza A strains of M SRM SRprovide effective protection against both homologous and heterologous viruses in both mice and ferretsIn our previous Phase I awardwe generated an influenza B M SRBM SRvaccine and demonstrated that it also provided effective protection against homologous and heterologous influenza B viruses in a mouse modelInterestinglythere appear to be some differences in the mechanism of protection between M SR and BM SR vaccinesIn the current Phase II grantwe will investigate the efficacy and safety of the BM SR vaccine in a ferret modelwhich more closely resembles the viral infection in humansWe hypothesize that the vaccine will provide safe and effective protection against both homologous and heterologous influenza B infection in ferretsWe will also investigate the mechanism of protection in greater depthAimTo determine the efficacy and spectrum of protection afforded by the vaccine in ferretsAimTo evaluate the safety of the vaccine in ferretsAimTo investigate the mechanism of protection induced by BM SRThese studies will provide a comprehensive pre clinical evaluation of the efficacy and safety of the BM SR vaccineThe outcome of the studies is expected to have high impact on the fundamental understanding of the mechanism of protection of the BM SR influenza B vaccine and to progress FluGen s vaccine program toward a quadrivalent human clinical trial PROJECT NARRATIVE Seasonal influenza viruses infectof the population resulting in betweenanddeaths and up tohospitalizations per year in the US aloneA significant proportion of this morbidity and mortality is caused by influenza B virusesHowevercurrent vaccines are only aroundeffective in normal healthy peoplehave very low efficacy in vulnerable populations such as the elderlyand provide poor cross reactive protection against newly emerging strainsThere is an urgent need for a highly effective and safe vaccine for influenza Bwhich we propose can be met by FluGenandapos s new BM SR vaccine platform